MAUDE Adverse Event Report: COVIDIEN J011RO JOEY ADAPUTER TYPE X30; PUMP, INFUSION, ENTERAL

Model Number J011RO

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reported that the nutrition leaked right after the feeding started.It was confirmed that the silicon tube has been damaged.There was no patient injury.

Manufacturer Narrative

A review of the device history record could not be conducted because a lot number was not provided.One sample was evaluated.The reported condition was confirmed.The investigation found a leak in the silicone tube coming from the pin hole.Corrective/preventive action (capa) will be addressed in a formal capa which is currently awaiting implementation.

• Brand Name: J011RO JOEY ADAPUTER TYPE X30
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 117 moo 2, petchkasem rd, samp; nakorn pathom 73110 ; TH 73110
• MDR Report Key: 9451174
• MDR Text Key: 170274834
• Report Number: 8040459-2019-00508
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: J011RO
• Device Catalogue Number: J011RO
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/05/2019
• Patient Sequence Number: 1